NCT02955108

Brief Summary

The objective of this study is to look at the effects of distractive auditory stimuli (DAS) on reducing dyspnea intensity and related anxiety and increasing exercise tolerance. Investigators hope that compared to a no-music control condition, that under a music condition participants with COPD will (a) demonstrate increased self-paced walk distance and enjoyment; (b) have less dyspnea intensity, (c) experience less dyspnea anxiety; (d) have less fatigue and state anxiety; and (e) higher maximum heart rate. The upbeat music with a tempo of 90 - 100 bpm (an average-to-moderate walking tempo) is expected to have distractive and performance enhancing effects in order to increase tolerance to dyspnea and exercise. The long-term goal of this study is to increase physical activity in adults with COPD and RLD by promoting dyspnea and fatigue management through use of distractive auditory stimuli in the form of music.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for not_applicable chronic-obstructive-pulmonary-disease

Timeline
Completed

Started Oct 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 2, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 4, 2016

Completed
12 months until next milestone

Study Start

First participant enrolled

October 27, 2017

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 14, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 14, 2018

Completed
Last Updated

August 3, 2021

Status Verified

July 1, 2021

Enrollment Period

1 year

First QC Date

November 2, 2016

Last Update Submit

July 30, 2021

Conditions

Chronic Obstructive Pulmonary Disease

Outcome Measures

Primary Outcomes (1)

  • Dyspnea Intensity (DI)

    Borg Breathlessness Scale. The Borg dyspnea scale is a single-item rating scale, ranging between 0, "nothing at all", and 10, "very, very severe (maximal)". Patients will be asked to rate their level of dyspnea during the walk test using the 10-point Borg scale after the 6MWT.64 Validity of the Borg scale for measuring dyspnea intensity has been shown.65

    60 Minutes

Study Arms (2)

music first then no music

EXPERIMENTAL
Procedure: Distractive Auditory StimuliProcedure: No Distractive Auditory Stimuli

no music first then music

EXPERIMENTAL
Procedure: Distractive Auditory StimuliProcedure: No Distractive Auditory Stimuli

Interventions

Distractive Auditory StimuliPROCEDURE

Participants will self-select 1 music piece from a list of choices to keep the rhythm and tempo consistent throughout the 6MWT. The instructions to participants for selecting the music will be standardized. TThe music volume will be standardized to be "moderately loud" as rated by participants for the music condition. Participants will not be specifically instructed to synchronize their walking movements with the music tempo. The music is based on a cognitive therapy (distraction) strategy conceptual framework. Music will be played during the 6MWT (in-task) only.

music first then no musicno music first then music
No Distractive Auditory StimuliPROCEDURE

Participants will wear headphones with no music playing

music first then no musicno music first then music

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • English speaking
  • aged 40 years or older, with physician-diagnosed COPD
  • a flow volume loop with a FEV1/FVC of \< 0.70 in the past 12 months
  • medically cleared to participate in NYULMC's pulmonary rehabilitation program.

You may not qualify if:

  • Inability to exercise due to musculoskeletalor neurological dysfunction
  • Inability to walk independently (unaided)
  • deafness or severe hearing impairment requiring hearing aids
  • mMRC score = 0 ("I only get breathlessness with strenuous exercise").

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

New York University School of Medicine

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Anna Maria Norweg

    New York University Medical School

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 2, 2016

First Posted

November 4, 2016

Study Start

October 27, 2017

Primary Completion

November 14, 2018

Study Completion

November 14, 2018

Last Updated

August 3, 2021

Record last verified: 2021-07

Locations

US(1)